adultburn: Virtual Reality in Lower Limb Adult Burn

Sponsor
Qassim University (Other)
Overall Status
Completed
CT.gov ID
NCT04677764
Collaborator
Cairo University (Other)
34
2
39.6

Study Details

Study Description

Brief Summary

To investigate the potential effects of Wii fit rehabilitation programs on functional capacity, mobility, balance and muscle strength in lower limb burn patients after hospital discharge.

Condition or Disease Intervention/Treatment Phase
  • Other: virtual reality
  • Other: Standard of care
N/A

Detailed Description

The use of virtual reality technology in burn conditions improved joint flexibility and reduced pain associated with physical therapy, dressing changes, and wound debridement. However, the primary concern of burn rehabilitation is not only survival but also maximizing functional outcome and decreasing the time for return to work.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
A blinded author to group allocation collected the outcome measures at baseline and after 12 weeks of intervention period.
Primary Purpose:
Treatment
Official Title:
Efficacy of Wii Fit Training on Lower Limb Burn in Adults
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Aug 20, 2019
Actual Study Completion Date :
Aug 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Wii Fit Group

Received Standard of care and Wii Fit protocol consisted of strength, balance, and aerobic programs that were performed on the Wii Fit balance board (Nintendo Inc., Kyoto, Japan). For muscle strengthening exercise, lunges, single-leg extensions, sideways leg lifts, single leg twists, and rowing squats were performed. For exercise that enhances balancing sense, the soccer heading, ski slalom, penguin, table tilt, and balance bubble games were used. Aerobic games as hula hoop, super hula hoop and basic step.

Other: virtual reality
Wii Fit balance board (Nintendo Inc., Kyoto, Japan).
Other Names:
  • interactive video games
  • Other: Standard of care
    physical therapy and occupational therapy exercises either at their own home or a gym
    Other Names:
  • routine physical therapy protocol
  • Other: Standard of care group

    On discharge from the hospital, patients in the SOC group were given instructions on how to perform physical therapy and occupational therapy exercises after discharge. After education, patients could perform the physical therapy and occupational therapy exercises either at their own home or a gym.

    Other: Standard of care
    physical therapy and occupational therapy exercises either at their own home or a gym
    Other Names:
  • routine physical therapy protocol
  • Outcome Measures

    Primary Outcome Measures

    1. high mobility assessment tool [at baseline]

      used to assess mobility assessment after burn injuries. It is a valid and reliable unidimensional assessment tool which includes nine functional tasks, where 0 = inability to do and 4= able to do extremely well, with a total score of 54. Each Functional task is rated on a five-point performance scale with higher scores indicate a higher level of performance

    2. high mobility assessment tool [after 12 weeks]

      used to assess mobility assessment after burn injuries. It is a valid and reliable unidimensional assessment tool which includes nine functional tasks, where 0 = inability to do and 4= able to do extremely well, with a total score of 54. Each Functional task is rated on a five-point performance scale with higher scores indicate a higher level of performance

    3. Lower Limb Functional Index [at baseline]

      a valid and reliable patient self-reported questionnaire to assess lower limb function for patients with a burn injury. It is consisted of fifteen general and ten lower-limb specific items that assess the functional status of the patients during the last 2-3 days. The scoring options for the LLFI Items are Yes=1 point, Somewhat= 0.5 point and No= 0 point. The scoring points are added and then multiplied by four for a total score of functional limitation. The total score of the LLFI ranges from 0 (maximum limitation) to 100 (no limitation or normal functional status)

    4. Lower Limb Functional Index [after 12 weeks]

      a valid and reliable patient self-reported questionnaire to assess lower limb function for patients with a burn injury. It is consisted of fifteen general and ten lower-limb specific items that assess the functional status of the patients during the last 2-3 days. The scoring options for the LLFI Items are Yes=1 point, Somewhat= 0.5 point and No= 0 point. The scoring points are added and then multiplied by four for a total score of functional limitation. The total score of the LLFI ranges from 0 (maximum limitation) to 100 (no limitation or normal functional status)

    5. Timed-up and go test [at baseline]

      used to evaluate functional mobility of the patients that requires both static and dynamic balance. The TUG test is a basic mobility assessment tool which records the time taken to stand up from a chair, walk 3 meters, return and sit down on the chair. The TUG test was performed with a standardized instruction, asking patients to walk as fast as possible during the test. All participants performed the TUG test from a standard chair (seat height of approximately 46 cm) with back support and no arms

    6. Timed-up and go test [after 12 weeks]

      used to evaluate functional mobility of the patients that requires both static and dynamic balance. The TUG test is a basic mobility assessment tool which records the time taken to stand up from a chair, walk 3 meters, return and sit down on the chair. The TUG test was performed with a standardized instruction, asking patients to walk as fast as possible during the test. All participants performed the TUG test from a standard chair (seat height of approximately 46 cm) with back support and no arms

    Secondary Outcome Measures

    1. The six-minute walk test [at baseline]

      used to assess functional exercise capacity of the participants. The 6-MWT was performed in a 30-meters flat corridor according to the American Thoracic Society guidelines. Patients were asked to walk as far as possible in the 30-m corridor during the 6-min period. Standardized verbal encouragement is given to the patients during the 6-MWT. At the end of the test, the walking distance was measured. The predicted values of 6-MWT were calculated according to age and gender

    2. The six-minute walk test [after 12 weeks]

      used to assess functional exercise capacity of the participants. The 6-MWT was performed in a 30-meters flat corridor according to the American Thoracic Society guidelines. Patients were asked to walk as far as possible in the 30-m corridor during the 6-min period. Standardized verbal encouragement is given to the patients during the 6-MWT. At the end of the test, the walking distance was measured. The predicted values of 6-MWT were calculated according to age and gender

    3. Isokinetic Muscle Strength Assessment [at baseline]

      assessed by A Biodex dynamometer (Biodex Medical System, Shirley, NY, USA). The values of knee flexors and extensors muscle peak torque of dominant leg were measured regardless the location of burns at an angular velocity of 150°/seconds, hip angle of 100° and patient were supported with a securing belt placed over the mid- thigh, pelvis and trunk. Three sub-maximal repetitions were allowed for the patient without any load as a warm-up. The patient then carried out 10 of maximum voluntary muscle contractions continuously without rest and the highest values were recorded for analysis.

    4. Isokinetic Muscle Strength Assessment [after 12 weeks]

      assessed by A Biodex dynamometer (Biodex Medical System, Shirley, NY, USA). The values of knee flexors and extensors muscle peak torque of dominant leg were measured regardless the location of burns at an angular velocity of 150°/seconds, hip angle of 100° and patient were supported with a securing belt placed over the mid- thigh, pelvis and trunk. Three sub-maximal repetitions were allowed for the patient without any load as a warm-up. The patient then carried out 10 of maximum voluntary muscle contractions continuously without rest and the highest values were recorded for analysis.

    5. Stability Index [at baseline]

      assessed by A Biodex Balance System (Biodex Medical Systems, Shirley, NY) which consists of a movable balance platform that provides 20° surface tilt through 360° range of motion. The platform interfaces with computer software that enables the device to serve as an objective assessment of balance. All measurements were performed at level eight of stability, and the test duration was set at 20 seconds for three successive trials.

    6. Stability Index [after 12 weeks]

      assessed by A Biodex Balance System (Biodex Medical Systems, Shirley, NY) which consists of a movable balance platform that provides 20° surface tilt through 360° range of motion. The platform interfaces with computer software that enables the device to serve as an objective assessment of balance. All measurements were performed at level eight of stability, and the test duration was set at 20 seconds for three successive trials.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • adult with a deep partial thickness or a full thickness burn in the lower extremities.

    • induced by either a scaled or a flame thermal burn.

    • total body surface area (TBSA) more than 40%.

    • age ranged from 18 to 40 years.

    • recent hospital discharge.

    Exclusion Criteria:
    • Infection.

    • Diabetes.

    • inhalation injury.

    • Fracture.

    • degenerative joint diseases of the lower extremities.

    • peripheral nerve diseases.

    • Pre-established psychologically and physically disorders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qassim University
    • Cairo University

    Investigators

    • Principal Investigator: Maged Basha, Qassim University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maged Basha, Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah., Qassim University
    ClinicalTrials.gov Identifier:
    NCT04677764
    Other Study ID Numbers:
    • 2657PT
    First Posted:
    Dec 21, 2020
    Last Update Posted:
    Dec 21, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maged Basha, Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah., Qassim University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 21, 2020